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The Market for Organ and Tissue Transplantation and Alternatives

Published by: BCC Research

Published: Oct. 1, 2005 - 343 Pages


Table of Contents



INTRODUCTION

STUDY GOAL AND OBJECTIVES

REASONS FOR DOING THE STUDY

CONTRIBUTIONS OF THE STUDY AND FOR WHOM

SCOPE AND FORMAT

METHODOLOGY

INFORMATION SOURCES

AUTHOR'S CREDENTIALS

RELATED BCC PUBLICATIONS

BCC ONLINE SERVICES

DISCLAIMER



SUMMARY

Summary Table:

NUMBER OF PROCEDURES AND VALUE OF U.S. ORGAN AND TISSUE TRANSPLANTATION MARKETS, THROUGH 2010

Summary Figure:

NUMBER OF PROCEDURES AND VALUE OF U.S. ORGAN AND TISSUE TRANSPLANTATION MARKETS, 2005 AND 2010



OVERVIEW

IMPORTANCE OF THE INDUSTRY

ORGANS

Table 1 U.S. ORGAN TRANSPLANTS: AVERAGE FIRST YEAR COST, NUMBER OF PROCEDURES AND VALUE BY TYPE OF ORGAN TRANSPLANT, THROUGH 2010

KIDNEY

LIVER

HEART

LUNG

INTESTINE

PANCREAS

WAITING LISTS

Waiting Lists Grow Faster than Numbers of Transplantations

Table 2 PATIENTS ON U.S. WAITING LISTS AT THE END OF THE YEARS BY TYPE OF ORGAN TRANSPLANT, 1999-2003

INTERNATIONAL TRENDS

Limited Supply Puts Brakes on Transplantations

Table 3 NUMBERS OF DONATED CADAVERS BY REGION, 1997-2003

TISSUES

AGING BABY BOOMERS DRIVE THE MARKET

Table 4 TISSUE GRAFTING IN THE U.S. BY TISSUE TYPE, THROUGH 2010 (NUMBER OF PROCEDURES)

Figure 1 TISSUE GRAFTING IN THE U.S., 2005 AND 2010 (NUMBER OF PROCEDURES)

CORNEA

BLOOD STEM CELLS

BONE ALLOGRAFTS

HEART VALVES

VASCULAR TISSUE

SKIN AND COLLAGEN

APPLICATIONS

THE TRANSPLANTATION PROCESS

PREPARATION

SURGERY

RECUPERATION

MAINTENANCE

PRODUCTS IN THE TRANSPLANTATION PROCESS

HLA TISSUE TYPING

The World Market for HLA Typing

Table 5 WORLD MARKET FOR HLA TYPING, THROUGH 2010 ($ MILLIONS)

The U.S. Market for HLA Typing

Table 6 U.S. MARKET FOR HLA TYPING, THROUGH 2010 ($ MILLIONS)

Splitting the Market

ORGAN PRESERVATION PRODUCTS

ANTIREJECTION DRUGS

ANTI-INFECTIVES

Table 7 WORLD MARKET FOR ANTI-INFECTIVES USED FOR TRANSPLANT PATIENTS, THROUGH 2010 ($ MILLIONS)

POSTTRANSPLANT MONITORING

Table 8 WORLD MARKET FOR POSTTRANSPLANT MONITORING, THROUGH 2010 ($ MILLIONS)

ALTERNATIVES TO TRANSPLANTATION

GOVERNMENT REGULATION AND PATENTS

EVOLUTION OF TRANSPLANTATION

TISSUE TYPING

IMMUNOSUPPRESSION

PRESERVATION

Improvements in Cold Ischemia Time

Table 9 COLD ISCHEMIA TIMES FOR KIDNEYS, 1998-2002 (HOURS)

GOVERNMENT REIMBURSEMENT OF TRANSPLANTATION COSTS

MECHANICAL ORGANS

GENERAL TRENDS



SUPPLY MANAGEMENT

REDUCING WASTE AND REJECTION

INCREASING THE HARVEST

Table 10 RECOVERED ORGANS NOT USED BY TYPE, 1998-2003

Table 11 CONSENTED ORGANS NOT RECOVERED BY TYPE, 1998-2003

BETTER HARVESTING

Definition of Brain Death

Papworth Cocktail

Remembering the Ultimate Customer: the Patient on the Waiting List

LESS WASTE

PRESERVATION

Rinse and Preservation Solutions

Table 12 MAJOR ORGAN PRESERVATION SOLUTIONS

Celsior

Collins Solution

Custodiol

Hypothermosol

ViaSpan

The Market for Preservation Solutions

Table 13 NORTH AMERICAN AND WORLD MARKETS FOR ORGAN PRESERVATION SOLUTIONS (EXCEPT PAPWORK COCKTAIL), THROUGH 2010

Organ Preservation Products in Development

Machine Perfusion

Bio-Preserve International

TransMedics, Inc.

Waters Medical Systems

NON-HEART-BEATING DONORS

TESTING

Blood Typing

Tissue Typing

Panel Reactive Antibodies (PRA)

Table 14 TISSUE TYPING TECHNOLOGIES

Advances

Table 15 SELECTED COMPETITORS IN THE HLA TYPING MARKET

Plasmapheresis: Transplantation without Matching Antigens

Posttransplant Testing

Biotronik

Data Sciences

Isis

Reperfusion Injury

FIGHTING REJECTION

Table 16 NUMBER OF PATIENTS IN THE U.S. WHO ARE ON WAITING LISTS BECAUSE OF GRAFT FAILURE (FAILURE OF PREVIOUSLY TRANSPLANTED ORGAN), ALL ORGANS, 1995-2003

Table 17 PERCENT OF U.S. PATIENTS ON WAITING LISTS BY ORGAN WHO PREVIOUSLY HAD A TRANSPLANT, 2000-2003 (%)

Table 18 U.S. ORGAN RECIPIENTS WHO PREVIOUSLY HAD A TRANSPLANT: ALL ORGANS, 1995-2004

Table 19 NUMBERS OF PEOPLE IN THE U.S. LIVING WITH A FUNCTIONING TRANSPLANT BY TYPE, 1998-2003

IMMUNOSUPPRESSIVE DRUG THERAPY

Improvements in Products and Survival Times

Table 20 ANTIREJECTION DRUGS APPROVED IN THE U.S., BY CLASS

Usual Antirejection Drug Protocols

Induction Therapy

Table 21 IMMUNOSUPPRESSANT USE FOR INDUCTION, BY ORGAN (%)

Maintenance Therapy



Table 22 COMMON IMMUNSUPPRESSIVE REGIMENS

Table 23 COMMONLY USED INTRAVENOUS IMMUNOSUPPRESIVE DRUGS

Table 24 IMMUNOSUPPRESSANT DRUG USE AT TRANSPLANT DISCHARGE, BY ORGAN (%)

Table 25 IMMUNOSUPPRESSANT DRUG USE, BY ORGAN, AT END OF FIRST-YEAR POSTTRANSPLANT (%)

Rejection Therapy

Risks Associated with Immunosuppressive Therapy

Annual Cost of Immunosuppressant Drugs

Comparison of Annual Cost of Two Immunosuppressant Drug Regimens during the First Year Following Transplantation

The Market for Immunosuppressant Drug Therapy

Table 26 WORLDWIDE MARKET FOR IMMUNOSUPPRESSION IN SOLID ORGAN TRANSPLANT RECIPIENTS, THROUGH 2010

Table 27 WORLDWIDE SALES OF IMMUNOSUPPRESSIVES BY DRUG CATEGORY, THROUGH 2010 ($ MILLIONS)

Table 28 U.S. SALES OF IMMUNOSUPPRESSIVES BY DRUG CATEGORY, THROUGH 2010 ($ MILLIONS)

Table 29 WORLDWIDE SALES OF BRAND NAME IMMUNOSUPPRESSANT DRUGS BY COMPANY: 2004-2010 ($ MILLIONS)

Table 30 PERCENTAGE OF U.S. MARKET BY PRESCRIPTION VOLUME OF ANTIREJECTION DRUGS, 2004 (%)

Products

Antibodies

Table 31 MARKETED ANTIBODY PRODUCTS FOR TREATMENT OF ORGAN TRANSPLANT REJECTION

Monoclonal Antibody Products

Campath/MabCampath

Antithymocyte Globulin

Atgam

Thymoglobulin



The Market for Antibody Products to Treat Organ Transplant Rejection

Table 32 GLOBAL MARKET FOR ANTIBODY PRODUCTS TO TREAT ORGAN TRANSPLANT REJECTION: WORLDWIDE SALES FOR, THROUGH 2010 ($ MILLIONS)

Antibodies in Development for Organ Transplant Rejection

Table 33 THERAPEUTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE PREVENTION OF ORGAN TRANSPLANT REJECTION

Antiproliferative Agents

Azathioprine

CellCept

Certican

Myfortic

Calcineurin Inhibitors

Concern About Generics

Leading Cyclosporine Products

Pulminiq: the Newest Entrant to the Market



Prograf

TOR Inhibitors

Immunosuppressive Agents in Development

Table 34 IMMUNOSUPPRESSIVE AGENTS IN PHASE II OR LATER DEVELOPMENT

Generics

HOW THE MEDICARE DRUG DISCOUNT CARD PROGRAM AND THE MEDICARE DRUG BENEFIT WILL AFFECT TRANSPLANT PATIENTS



Table 35 MEDICARE IMMUNOSUPPRESIVE DRUG COVERAGE OVERVIEW



Table 36 MEDICARE IMMUNOSUPPRESIVE DRUG COVERAGE OVERVIEW (PART II)

EFFECT OF PATENT REFORM EFFORTS TO SHORTEN MONOPOLY TIMES ON TRANSPLANTATION DRUG RESEARCH

TRANSPLANTATION WITHOUT REJECTION

TOLERANCE

Antisense Therapy

Costimulation

Chimerism

Abgenix

Chimeric Therapies

ADDRESSING INFECTION

Table 37 COMMON POSTTRANSPLANT INFECTIONS

Table 38 COMMON POSTTRANSPLANT DRUGS

MONITORING

Table 39 WORLD MARKET FOR TRANSPLANT DRUG AND DISEASE-MONITORING AGENTS, THROUGH 2010 ($ MILLIONS)

THE EFFICIENCY DIVIDEND

TISSUE

FINDING MORE SUPPLY

EXPANDING TRADITIONAL SOURCES: OBTAINING MORE CADAVERS

Spain Sets Donation Standard

Table 40 INTERNATIONAL ORGAN DONOR RATES, 2000 (PER MILLION OF POPULATION)

The Uniform Anatomical Gift Act

Reforms to Boost Donation

Presumed Consent

Table 41 SELECTED COUNTRIES AND TYPE OF CONSENT



First-person Consent

Donor Compensation

Reimbursement for Donor Organs in the U.K.

Tapping New Sources: Expanding Donations to New Nations and Living Donors

Shifting Cadaveric Donation

Table 42 COUNTRIES WITH KIDNEY TRANSPLANT PROGRAMS

Table 43 KIDNEY, LIVER AND HEART TRANSPLANTS BY REGION, 2000



More Competition Splinters the Market

Organ Selling Meets Dammed Up Demand

Marketing Availability

Belgium and Austria

Costa Rica

Cuba

Pakistan

South Africa

Tissues

Effects of Globalization

ORGAN DONATION BREAKTHROUGH COLLABORATIVE

MAJOR U.S. TRANSPLANT CENTERS

Table 44 LEADING U.S. TRANSPLANT PROGRAMS (BY TOTAL NUMBER OF PROCEDURES PERFORMED BETWEEN JANUARY 1, 1988 AND MARCH 1, 2005)

Table 45 LEADING U.S. TRANSPLANT PROGRAMS BY NUMBER OF MULTIORGAN TRANSPLANT PROCEDURES PERFORMED BETWEEN JANUARY 1, 1988 AND MARCH 1, 2005

Living Donors

Table 46 TRENDS IN U.S. LIVING AND CADAVERIC DONATIONS, 2003-2010

TRENDS IN TRANSPLANTATION OF ALL ORGANS

Table 47 U.S. ORGAN TRANSPLANTS, 1998 TO 2004 (NUMBER OF PROCEDURES)

Survival Rates

Table 48 ONE-YEAR AND FIVE-YEAR PATIENT SURVIVAL RATES, BY ORGAN, FOR PATIENTS RECEIVING TRANSPLANTS BETWEEN 1998 AND 2003 (%)

Table 49 ONE-YEAR AND FIVE-YEAR GRAFT SURVIVAL RATES, BY ORGAN FOR TRANSPLANTS PERFORMED BETWEEN 1998 AND 2003 (%)

Kidney Exchanges

Incompatible Kidney Transplant Program

NEW TECHNOLOGIES

ORGANS FROM ANIMALS: XENOTRANSPLANTATION

ORGAN PRIMORDIA

NUCLEAR TRANSFER TO ELIMINATE THE REJECTION GENE

Porcine Endogenous Retrovirus

Competition Thins

Regulatory Issues

Political Problems

ARTIFICIAL ORGANS

REDUCING DEMAND

CELLULAR TRANSPLANTS

ORGANS

KIDNEY

TRANSPLANTATION STATISTICS

Table 50 NUMBER OF KIDNEY TRANSPLANTATIONS BY REGION, THROUGH 2010

THE MARKET FOR KIDNEY TRANSPLANTATION

Table 51 U.S. KIDNEY TRANSPLANT MARKET, THROUGH 2007 ($ MILLIONS)

Figure 2 U.S. KIDNEY TRANSPLANT MARKET, 2005 AND 2010 ($ MILLIONS)

LEADING U.S. KIDNEY TRANSPLANT PROGRAMS

Table 52 TOP FIVE U.S. KIDNEY TRANSPLANT PROGRAMS (BY TOTAL PROCEDURES PERFORMED FROM JANUARY 1, 1988 TO MARCH 1, 2005)

TRANSPLANTATION TOO RARE TO BE A SOLUTION

WAITING LIST

Table 53 WAITING LIST TRENDS FOR KIDNEYS BY SELECTED REGION, THROUGH 2010

Shortage is Worse in Japan

CADAVERIC VERSUS LIVING DONATION

Table 54 NUMBER OF U.S. KIDNEY TRANSPLANTATIONS FROM LIVING AND CADAVERIC DONORS, THROUGH 2010

CLOSING THE KIDNEY GAP

INDICATIONS

Table 55 LEADING CAUSES OF KIDNEY FAILURE, 2003

Table 56 LEADING CAUSES OF KIDNEY TRANSPLANTATION, 2004 (%)

OLDER RECIPIENTS

LESS REJECTION

Table 57 GRAFT FAILURE HAZARD RATIO (1993 = 1)

IMMUNOSUPPRESSION

Table 58 IMMUNOSUPPRESSIVE REGIMENS IN A SAMPLE POPULATION OF 113 KIDNEY TRANSPLANT PATIENTS

Drugs Used for Induction

Table 59 U.S IMMUNOSUPPRESSION USE FOR INDUCTION IN KIDNEY TRANSPLANTATION, 1998-2003 (%)

Drugs Used for Maintenance Prior to Discharge

Table 60 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE IN KIDNEY TRANSPLANTATION, 1998-2003 (%)



Drugs Used for Maintenance Between Discharge and One-year Posttransplant

Table 61 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN DISCHARGE AND ONE-YEAR POSTTRANSPLANT IN KIDNEY TRANSPLANTATION, 1998-2002 (%)

Drugs Used for Maintenance Between Transplant and One-year Posttransplant

Table 62 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN TRANSPLANT AND ONE-YEAR POSTTRANSPLANT IN KIDNEY TRANSPLANTATION, 1998-2002 (%)

The Market for Immunosuppressive Therapy for Kidney Transplantation

Table 63 U.S. SALES OF IMMUNOSUPPRESSIVES BY DRUG CATEGORY, THROUGH 2010 ($ MILLIONS)

Table 64 ESTIMATED U.S. MARKET FOR IMMUNOSUPPRESSIVES FOR KIDNEY TRANSPLANT PATIENTS, THROUGH 2010

ADVANCES IN KIDNEY TRANSPLANTATION

ALTERNATIVES

Mechanical

Medical

Animal

Cellular

PANCREAS

TRANSPLANTATION STATISTICS

Table 65 GROWTH OF WHOLE PANCREAS TRANSPLANTATION IN THE U.S. AND EUROPE, THROUGH 2010 (NUMBER OF PROCEDURES)

THE MARKET FOR PANCREAS TRANSPLANTATION

Table 66 U.S. WHOLE PANCREAS TRANSPLANTATION MARKET, THROUGH 2010 ($ MILLIONS)

Figure 3 U.S. WHOLE PANCREAS TRANSPLANTATION MARKET, 2005 AND 2010 ($ MILLIONS)

WAITING LIST

Table 67 U.S. PANCREAS WAITING LIST, THROUGH 2010

LEADING U.S. PANCREAS TRANSPLANT PROGRAMS

Table 68 TOP FIVE U.S. KIDNEY TRANSPLANT PROGRAMS (BY TOTAL PROCEDURES PERFORMED FROM JANUARY 1, 1988 TO MARCH 1, 2005)

IMMUNOSUPPRESSION

Drugs Used for Induction

Table 69 U.S. IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN PANCREAS TRANSPLANTATION, 1998-2003 (%)

Drugs Used for Maintenance Prior to Discharge

Table 70 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE AFTER PANCREAS TRANSPLANTATION, 1998-2003 (%)

Drugs Used for Maintenance between Discharge and One-year Posttransplant

Table 71 IMMUNOSUPPRESSION DRUG USE IN THE U.S. FOR MAINTENANCE BETWEEN DISCHARGE AND ONE-YEAR POSTTRANSPLANT FOR PANCREAS TRANSPLANTATION, 1998-2002 (%)

Drugs Used for Maintenance Between Transplant and One-year Posttransplant

Table 72 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN TRANSPLANT AND ONE-YEAR POSTTRANSPLANT IN PANCREAS TRANSPLANTATION, 1998-2002 (%)



CONTROVERSY

INDICATIONS

Table 73 ESTIMATED ANNUAL PER CAPITA PATIENT COSTS FOR DIABETES IN SELECTED COUNTRIES, 2004

ALTERNATIVES

Medical

Islet Cell Transplantation

Table 74 INTERNATIONAL AND U.S. PANCREAS GRAFT SURVIVAL RATES (%)

A Breakthrough

Juvenile Diabetes Research Foundation

Drawbacks

Cell Encapsulation

AmCyte Biomedical

Islet Technology

Pig-derived Islet Cells

Arbios Systems

Bioartificial Pancreas

Cerco Medical

IMEDD

Cultured Stem Cells

Protection of Islet Cells

Neurochem

COSTS

LIVER

HISTORY

TRANSPLANT STATISTICS

Table 75 GROWTH OF LIVER TRANSPLANTS BY REGION, THROUGH 2010 (NUMBER OF PROCEDURES)

THE MARKET FOR LIVER TRANSPLANTATION

Table 76 U.S. LIVER TRANSPLANT MARKET, THROUGH 2010 ($ MILLIONS)

Figure 4 U.S. LIVER TRANSPLANT MARKET, 2005 AND 2010 ($ MILLIONS)

LEADING U.S. LIVER TRANSPLANT PROGRAMS

Table 77 TOP FIVE U.S. LIVER TRANSPLANT PROGRAMS (BY TOTAL PROCEDURES PERFORMED FROM JANUARY 1, 1988 TO MARCH 1, 2005)

DONORS

Table 78 U.S. TRENDS IN LIVING DONOR LIVER TRANSPLANTS, 2000-2010

WAITING LIST

Table 79 REGIONAL GROWTH IN LIVER WAITING LISTS, THROUGH 2010

IMMUNOSUPPRESSION

Drugs Used for Induction

Table 80 U.S. IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN LIVER TRANSPLANTATION, 1998-2003 (%)

Drugs Used for Maintenance Prior to Discharge

Table 81 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE IN LIVER TRANSPLANTATION, 1998-2003 (%)

Drugs Used for Maintenance between Discharge and One-year Posttransplant

Table 82 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN DISCHARGE AND ONE-YEAR POSTTRANSPLANT FOR LIVER TRANSPLANTATION, 1998-2002 (%)



Drugs Used for Maintenance Between Transplant and One-year Posttransplant

Table 83 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN TRANSPLANT AND ONE-YEAR POSTTRANSPLANT FOR LIVER TRANSPLANTATION, 1998-2002 (%)

The Market for Immunosuppressive Drugs in Liver Transplantation

Table 84 U.S. MARKET FOR IMMUNOSUPPRESSANT DRUGS FIRST YEAR AFTER LIVER TRANSPLANTATION, THROUGH 2010 ($ MILLIONS)

INDICATIONS

Causes of Cirrhosis

TISSUE TYPING

ORGAN RECOVERY

REJECTION

Table 85 LIVER TRANSPLANT SURVIVAL RATES IN THE U.S. AND EUROPE (%)

ALTERNATIVES

Medical

Artificial Livers

Chemical/ Mechanical and /or Bioartificial Livers

Table 86 INDICATIONS FOR THE BIOARTIFICIAL LIVER



Table 87 BIOARTIFICIAL LIVERS IN DEVELOPMENT

Bioartificial Liver Support System

ELAD

LIVERAID

LiveRX 2000

Modular Extracorporeal Liver Support

Molecular Adsorption Recycling System

Relative Costs

HEART

TRANSPLANTATION STATISTICS

Table 88 DECLINING NUMBERS OF HEART TRANSPLANTATIONS BY REGION, THROUGH 2010 (NUMBER OF PROCEDURES)

THE MARKET FOR HEART TRANSPLANTATION

Table 89 U.S. HEART TRANSPLANT MARKET, THROUGH 2010 ($ MILLIONS)

LEADING U.S. HEART TRANSPLANT PROGRAMS

Table 90 TOP FIVE U.S. HEART TRANSPLANT PROGRAMS (BY TOTAL PROCEDURES PERFORMED FROM JANUARY 1, 1988 TO MARCH 1, 2005)

FEWER TRANSPLANTS DUE TO TIGHTER SUPPLY

Cultural Backlash

1995: A Peak Year

SHRINKING WAITING LISTS

Table 91 HEART WAITING LIST TRENDS, THROUGH 2010

IMMUNOSUPPRESSION

Drugs Used for Induction

Table 92 U.S. IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN HEART TRANSPLANTATION, 1998-2003 (%)

Drugs Used for Maintenance Prior to Discharge

Table 93 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE IN HEART TRANSPLANTATION, 1998-2003 (%)

Drugs Used for Maintenance Between Discharge and One-year Posttransplant

Table 94 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN DISCHARGE AND ONE-YEAR POSTTRANSPLANT IN HEART TRANSPLANTATION, 1998-2002 (%)



Table 95 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN TRANSPLANT AND ONE-YEAR POSTTRANSPLANT IN HEART TRANSPLANTATION, 1998-2002 (%)

The Immunosuppressive Drug Market for Heart Transplantation

Table 96 U.S. MARKET FOR ANTIREJECTION DRUGS AFTER HEART TRANSPLANTATION, FIRST-YEAR AFTER TRANSPLANT, THROUGH 2010

INDICATIONS

Table 97 LEADING CAUSES OF HEART FAILURE, 1999-2003 (%)

TISSUE TYPING

PRESERVATION

ALTERNATIVES

Medical

Angiogenesis Stimulators

Fibroblast Growth Factors



Nicotine

Gene Therapy



Animal

Surgical

Laser Revascularization

Mitral Valve Repair

Cardiac Support Devices

Mechanical

VAD Market

VAD Market

Table 98 U.S. MARKET FOR VADS, THROUGH 2010 ($ MILLIONS)

Table 99 U.S. MARKET FOR VADS USED AS DESTINATION THERAPY, THROUGH 2010 ($ MILLIONS)

DeBakey LVAS

HeartMate

Incor

LionHeart

Novacor

VADs Development in the U.S.

Table 100 LEFT VENTRICULAR ASSIST DEVICES IN DEVELOPMENT

Arrow International

CardiacAssist

Jarvik

MicroMed

Terumo

Thoratec

Ventracor

WorldHeart

Product Comparison

Medicare Changes Give the VAD Market a Boost

The Likelihood of Big Players Entering the Market

Total Artificial Hearts

AbioCor

CardioWest

Other Cardiac Assist Devices in Development

Regeneration Instead of Replacement

Cellular

LUNG

TRANSPLANTATION STATISTICS

Table 101 REGIONAL TRENDS IN LUNG TRANSPLANTATIONS, THROUGH 2010 (NUMBER OF PROCEDURES)

THE MARKET FOR LUNG TRANSPLANTATION

Table 102 U.S. LUNG TRANSPLANTATION MARKET, THROUGH 2010 ($ MILLIONS)

Figure 5 U.S. LUNG TRANSPLANTATION MARKET, 2005 AND 2010 ($ MILLIONS)

LEADING U.S. LUNG TRANSPLANT PROGRAMS

Table 103 TOP FIVE U.S. LIVER TRANSPLANT PROGRAMS (BY TOTAL PROCEDURES PERFORMED FROM JANUARY 1, 1988 TO MARCH 1, 2005)



IMMUNOSUPPRESSION

Drugs Used for Induction

Table 104 U.S. IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN LUNG TRANSPLANTATION, 1998-2003 (%)

Drugs Used for Maintenance Prior to Discharge

Table 105 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE IN LUNG TRANSPLANTATION, 1998-2003 (%)

Drugs Used for Maintenance between Discharge and One-year Posttransplant

Table 106 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN DISCHARGE AND ONE-YEAR POSTTRANSPLANT IN LUNG TRANSPLANTATION, 1998-2002 (%)



Drugs Used for Maintenance between Transplant and One-year Posttransplant

Table 107 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN TRANSPLANT AND ONE-YEAR POSTTRANSPLANT IN LUNG TRANSPLANTATION, 1998-2002 (%)

The Market for Immunosuppressive Drugs Used in Lung Transplantation

Table 108 U.S. MARKET FOR ANTIREJECTION DRUGS AFTER LUNG TRANSPLANTATION, FIRST YEAR AFTER TRANSPLANT, THROUGH 2010 ($ MILLIONS)

DONATION

Table 109 RECOVERED LUNGS NOT USED IN THE U.S., 1998-2003

Hormonal Resuscitation

WAITING LISTS

Table 110 LUNG WAITING LIST TRENDS, THROUGH 2010

REJECTION

Table 111 INTERNATIONAL AND U.S. LUNG TRANSPLANT AND GRAFT SURVIVAL RATES* (%)

INDICATIONS

Table 112 LEADING CAUSES OF CHRONIC LUNG FAILURE, 1998-2002 (%)

PRESERVATION

Celsior

Prolactin

ALTERNATIVES

Medical

Surgical

Cellular

HEART-LUNG

TRANSPLANTATION STATISTICS

Table 113 TRENDS IN HEART-LUNG TRANSPLANTATION BY REGION, THROUGH 2010 (NUMBER OF PROCEDURES)

THE MARKET FOR HEART-LUNG TRANSPLANTATION

Table 114 U.S. HEART-LUNG TRANSPLANT MARKET, THROUGH 2010 ($ MILLIONS)

Figure 6 U.S. HEART-LUNG TRANSPLANT MARKET, 2005 AND 2010 ($ MILLIONS)

THE LEADING U.S. HEART-LUNG TRANSPLANT PROGRAMS

Table 115 TOP FIVE U.S. LIVER TRANSPLANT PROGRAMS (BY TOTAL PROCEDURES PERFORMED FROM JANUARY 1, 1988 TO MARCH 1, 2005)

WAITING LIST

Table 116 HEART-LUNG WAITING LIST TRENDS, THROUGH 2010

SURVIVAL RATES

Table 117 INTERNATIONAL HEART AND HEART-LUNG TRANSPLANT PATIENT SURVIVAL RATES (%)

IMMUNOSUPPRESSION

Drugs Used for Induction

Table 118 U.S. IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN HEART-LUNG TRANSPLANTATION, 1998-2003 (%)

Drugs Used for Maintenance Prior to Discharge

Table 119 U.S IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE IN HEART-LUNG TRANSPLANTATION, 1998-2003 (%)

Drugs Used for Maintenance Between Discharge and One-year Posttransplant

Table 120 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN DISCHARGE AND ONE-YEAR POSTTRANSPLANT IN HEART-LUNG TRANSPLANTATION, 1998-2002 (%)

Table 121 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN TRANSPLANT AND ONE-YEAR POSTTRANSPLANT IN HEART-LUNG TRANSPLANTATION, 1998-2002 (%)

INTESTINE

HISTORY

TRANSPLANTATION STATISTICS

Table 122 INTERNATIONAL AND U.S. INTESTINE TRANSPLANT SURVIVAL RATES (%)

Table 123 U.S. SMALL BOWEL TRANSPLANTATION TRENDS, THROUGH 2010

THE MARKET FOR INTESTINE TRANSPLANTATION

Table 124 U.S. SMALL BOWEL TRANSPLANTATION MARKET, THROUGH 2010 ($ MILLIONS)

Figure 7 U.S. SMALL BOWEL TRANSPLANTATION MARKET, 2005 AND 2010 ($ MILLIONS)

LEADING U.S. INTESTINE TRANSPLANT PROGRAMS

Table 125 TOP FIVE U.S. LIVER TRANSPLANT PROGRAMS (BY TOTAL PROCEDURES PERFORMED FROM JANUARY 1, 1988 TO MARCH 1, 2005)



COUNTRIES WITH SMALL BOWEL TRANSPLANT PROGRAMS

Table 126 COUNTRIES WITH SMALL BOWEL TRANSPLANT PROGRAMS

LACK OF SURGICAL SUCCESS

TRANSPLANT TYPES

INDICATIONS

Table 127 LEADING INIDICATIONS FOR INTESTINE TRANSPLANT: ADULT PATIENTS, 2003 (%)

Table 128 LEADING INDICATIONS FOR INTESTINE TRANSPLANT: PEDIATRIC PATIENTS, 2003 (%)

IMMUNOSUPPRESSION

Drugs Used for Induction

Table 129 U.S IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN INTESTINE TRANSPLANTATION, 1998-2003 (%)

Drugs Used for Maintenance Prior to Discharge

Table 130 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE IN INTESTINE TRANSPLANTATION, 1998-2003 (%)

Drugs Used for Maintenance Between Discharge and One-year Posttransplant

Table 131 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN DISCHARGE AND ONE-YEAR POSTTRANSPLANT IN INTESTINE TRANSPLANTATION, 1998-2002 (%)

Drugs Used for Maintenance Between Transplant and One Year Posttransplant

Table 132 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN TRANSPLANT AND ONE YEAR POSTTRANSPLANT IN INTESTINE TRANSPLANTATION, 1998-2002 (%)

The Market for Immunosuppressive Drugs Used in Intestine Transplantation

Table 133 U.S. MARKET FOR ANTIREJECTION DRUGS AFTER SMALL BOWEL TRANSPLANTATION, FIRST YEAR AFTER TRANSPLANTATION, THROUGH 2010 ($ MILLIONS)

INFECTION PROPHYLAXIS

ALTERNATIVES

Medical

Mechanical

Cellular



TISSUES

OVERVIEW

MANDATORY REFERRALS

PUBLIC CYNICISM

DONOR COMPENSATION

CORNEA

Table 134 CORNEAL TRANSPLANTS IN SELECTED COUNTRIES, 1999-2003

Table 135 CORNEAL TRANSPLANTS AND U.S. MARKET, THROUGH 2010

Figure 8 U.S. CORNEAL TRANSPLANT MARKET, 2005 AND 2010 ($ MILLIONS)

Donors

Table 136 NUMBER OF U.S. CORNEA DONORS, 1999-2004

Waiting Lists

U.S.

Other Countries

Indications

Tissue Testing

Preservation

Cryopreservation

Immunosuppression

Alternatives

Surgical

Artificial Corneas

RETINAL DEGENERATION

Cellular Transplants

Gene Therapy

Electronic Implants

BLOOD STEM CELLS

HISTORY

First Successful Transplant

Donor Registry Established

Cord Blood

Cord Blood Banking

PROCEDURE VOLUMES

Table 137 ESTIMATED U.S. BONE MARROW TRANSPLANTS, 1998-2004

Table 138 PROJECTED U.S. BONE MARROW TRANSPLANT PROCEDURES, THROUGH 2010

Autologous Passes Allogeneic

Less Bone Marrow

DONORS

Table 139 BMDW MEMBER HOME COUNTRIES

Potential for HLA Testing

Table 140 NUMBERS OF BONE MARROW DONORS PER 10,000 INHABITANTS



WAITING LISTS

REJECTION

Table 141 U.S. MARKET FOR IMMUNOSUPPRESSIVE DRUG THERAPY FOLLOWING BONE MARROW TRANSPLANTATION, THROUGH 2010 ($ MILLIONS)

Table 142 U.S. MARKET FOR IMMUNOSUPPRESSIVE DRUG THERAPY FOLLOWING BLOOD STEM CELL TRANSPLANTATION, THROUGH 2010 ($ MILLIONS)

INDICATIONS

IMMUNOSUPPRESSION

Abgenix

University of Pennsylvania

ALTERNATIVES

Expanding Cord Blood

Replicell

BONE

HISTORY

PROCEDURES

Table 143 U.S. BONE GRAFT PROCEDURE VOLUMES BY APPLICATION, THROUGH 2010

Table 144 U.S. BONE GRAFT PROCEDURE VOLUMES BY TYPE OF GRAFT, THROUGH 2010

MARKET TOTALS

Table 145 U.S. AND WORLDWIDE ORTHOPEDIC IMPLANT MARKET GROWTH, THROUGH 2010 ($ BILLIONS)

Figure 9 U.S. AND WORLDWIDE IMPLANT MARKET GROWTH, 2005 AND 2010 ($ BILLIONS)

AUTOGRAFTS

ALLOGRAFTS



Risks Associated with Allografts

Products

Base Tissue

Demineralized Bone Matrix Products

Machined Implants

The Market for Allografted Tissue

Table 146 U.S. AND WORLD VALUES OF THE BONE ALLOGRAFT MARKET, THROUGH 2010 ($ MILLIONS)

Figure 10 VALUE OF THE U.S. AND WORLD BONE ALLOGRAFT MARKET, 2005 AND 2010 ($ MILLIONS)

Table 147 U.S. SALES OF BONE ALLOGRAFTS BY TYPE, THROUGH 2010 ($ MILLIONS)

Figure 11 U.S. SALES OF BONE ALLOGRAFTS BY TYPE, 2005 AND 2010 ($ MILLIONS)

BONE GRAFT SUBSTITUTES

Table 148 COMPARISON OF BONE GRAFT MATERIALS

Table 149 SUBSTITUTE BONE GRAFT TYPES

FACTOR-BASED BONE GRAFT SUBSTITUTES



Bone Morphogenic Proteins (BMPs)

InductOs

INFUSE® Bone Graft



Ne-Osteo

OP-1 Implant®

Skelite®

THE MARKET FOR BONE GRAFT PRODUCTS

Table 150 WORLDWIDE MARKET FOR BONE GRAFT PRODUCTS, THROUGH 2010 ($ MILLIONS)

INDICATIONS

TISSUE TESTING

Preventing Infection

PRESERVATION

COMPETITION

ALTERNATIVES

Animal Bone Grafts

Medical

Synthetic Materials

Orthovita

Spine Wave

Meniscus Allografts

Collagen Meniscus Implant

REPLACEMENT HEART VALVES, ARTERIES AND OTHER VESSELS

HISTORY

INDICATIONS

PROCEDURES

Table 151 NUMBER OF U.S. HEART VALVE TRANSPLANTS AND BYPASS OPERATIONS, 1998-2004

DONORS

Valves from Morgues

HEART VALVE ALLOGRAFT MARKET

Table 152 U.S. AND WORLD HEART VALVE TRANSPLANT MARKET, THROUGH 2010 ($ MILLIONS)

TISSUE TESTING

PRESERVATION AND PROCESSING

Synthetics

Xenografts

Defects and Regulation

ADVANCES

ALTERNATIVES

Animal

Stentless Valves

Calcification

Surgical

Coronary Bypass Grafts

Medical

Heart Valve and Vascular Disease

Mechanical/Synthetic

Improving Blood Flow

Better Maintenance

Tissue Valves Gain Popularity

Major Competitors

VASCULAR GRAFTS

Waiting List

Indications

Advances

Products

Tissue Engineering of Vascular Grafts

Alternatives

Gene Therapy



SKIN

Table 153 U.S. MARKET FOR HUMAN SKIN-BASED PRODUCTS, THROUGH 2010

HISTORY

INDICATIONS

Burns

Wounds

Venous Ulcers

Table 154 ESTIMATED INCIDENCE OF VENOUS ULCERS IN THE U.S. OVER-64 POPULATION, THROUGH 2010

Diabetic Ulcers

Table 155 ESTIMATED U.S. INCIDENCE OF DIABETIC FOOT ULCERS, THROUGH 2010

Pressure Ulcers

Urinary Incontinence and Other Uses

Table 156 U.S. TENDON, CARTILAGE AND MUSCLE GRAFTS, 1998-2004

REJECTION

TISSUE TESTING

PRESERVATION

Alternatives

Animal-based Products

Biobrane

OaSIS

Medical

Artificial Skin/Skin Replacement Products

AlloDerm

Apligraf

Cymetra

Dermagraft

Epicel

Integra Products

OrCel

TransCyte

Manufacturers of Artificial Skin and Skin Replacement Products

Table 157 MANUFACTURERS OF ARTIFICIAL SKIN AND SKIN REPLACMENT PRODUCTS

The Market for Artificial Skin and Skin Replacment Products

Table 158 ESTIMATED WORLDWIDE MARKET FOR ARTIFICIAL SKIN AND SKIN REPLACEMENT PRODUCTS, THROUGH 2010 ($ MILLIONS)

Table 159 ESTIMATED U.S. MARKET FOR ARTIFICIAL SKIN AND SKIN REPLACEMENT PRODUCTS, THROUGH 2010 ($ MILLIONS)

Products in Development

Other Research

REGULATION

CELLULAR TRANSPLANTATION

HISTORY

FOUR TYPES OF CELLS OFFER POTENTIAL

NUMBERS

DONORS

REJECTION

INDICATIONS

PATENTS

New Rule Requires Demonstrating Specific and Substantial Utility

ALTERNATIVES



COMPANY PROFILES

ABIOMED, INC.

BUSINESS OVERVIEW

ABIOMED DEVELOPS, MANUFACTURES AND MARKETS MEDICAL PRODUCTS TO SUPPORT, REPLACE OR ALLOW RECOVERY OF THE PUMPING FUNCTION OF A FAILING HEART.

FINANCIAL INFORMATION

PRODUCTS

CORPORATE STRATEGY

ARBIOS SYSTEMS, INC.

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

CORPORATE STRATEGY

ARROW INTERNATIONAL, INC.

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

ASTELLAS PHARMA INC.

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

CHIRON CORP.

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

CRYOLIFE, INC.

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS AND SERVICES

EXACTECH, INC.

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

CORPORATE STRATEGY

GAMBRO AB

BUSINESS OVERVIEW

FINANICAL INFORMATION

PRODUCTS

CORPORATE STRATEGY

GENZYME CORP.

WEB SITE: WWW.GENZYME.COM

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

CORPORATE STRATEGY

HEMOCLEANSE, INC.

BUSINESS OVERVIEW

PRODUCTS

CORPORATE STRATEGY

LIFECELL CORP.

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

CORPORATE STRATEGY

MEDTRONIC, INC.

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

CORPORATE STRATEGY

MILLENIUM BIOLOGIX, INC.

BUSINESS OVERVIEW

PRODUCTS



CORPORATE STRATEGY

NOVARTIS AG

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

ORGANOGENESIS, INC.

BUSINESS OVERVIEW

PRODUCTS

CORPORATE STRATEGY

ORTEC INTERNATIONAL, INC.

BUSINESS OVERVIEW

PRODUCTS

CORPORATE STRATEGY

PROTEIN DESIGN LABS

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

CORPORATE STRATEGY

SYNCARDIA SYSTEMS, INC.

BUSINESS OVERVIEW

PRODUCTS

CORPORATE STRATEGY

THORATEC CORP.

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

CORPORATE STRATEGY

WORLDHEART CORP.

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

CORPORATE STRATEGY

WYETH

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

Abstract

Organ failure and tissue loss account for half the medical spending in the U.S. In theory, transplantation is the last therapeutic option available to people in the final stage of an organ or tissue failure. In reality, the supply of organs or tissues is so limited that for the vast majority of people, transplantation is not an option. At the same time, transplantation outcomes are under renewed scrutiny as insurers try to control healthcare costs.

The organ transplantation business currently faces some of its toughest challenges and hurdles. At the same time, exciting fields of research offer hope for overcoming those challenges. Hence, tremendous opportunities exist to meet growing market demand and to cut costs. But, at the same time, competitors have great opportunities to provide equivalent outcomes at reduced cost. This report is a valuable tool for anyone assessing the organ and tissue transplantation market and attempting to devise a strategy to address it successfully.

This BCC study provides an in-depth analysis and forecast of the organ and tissue transplantation markets. The focus is on products and procedures used or under development including techniques, therapies, drugs and diagnostics.

SCOPE OF STUDY

The report contains:
  • Full coverage of product segments including solid organs, experimental xenografts and artificial organs; tissue transplants and cell transplants
  • Forecasts by product type and application through 2010, including supporting analyses for projections
  • An overview of international markets
  • Discussion of the industry’s structure and the regulatory environment
  • Profiles of leading companies involved including placement within the market and strategic analyses of available and emerging products.
METHODOLOGY

Information for this report was derived from a variety of sources, including that provided by product managers, marketing strategists, research executives and others at leading companies in the tissue transplantation market and at companies poised to enter the market. Others consulted include transplant surgeons, directors of transplant programs or tissue typing laboratories, and other medical professionals who participate in processes involved with transplantation, or who compete against it. Other data came from company annual reports and 10Ks, journal articles, prospectus assessments, government resources and from healthcare institutions.

INFORMATION SOURCES

Information for this report was obtained from primary interviews with companies, industry analysts, healthcare personnel, Center for Medicare and Medicaid Services (CMS) and other government agencies, literature searches, annual reports, 10Ks and product literature.

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